- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04180358
Capacity Builders Inc. Navajo Youth Builders Personal Responsibility Education Innovation Strategies Project (PREIS)
Capacity Builders Inc. Navajo Youth Builders Personal Responsibility Education Innovation Strategies Project Effectively Educating Navajo Youth on the Prevention of Adolescent Pregnancy, Sexually Transmitted Infections, and HIV/AIDS
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Capacity Builders (CBI) will implement the Youth Builders PREIS curriculum Native STAND, recruiting Navajo youth in grades 9-11 and between the ages 14-18 who attend school in the Consolidated School District in New Mexico. Using the Theory of Reasoned Action as a theoretical framework, the curriculum will be administered in classrooms over 27 sessions lasting 45 minutes. The curriculum will entail lessons conducted in either Physical Education or Health Classes and youth will be randomly assigned to two groups by the local program evaluator. Youth will be required to obtain signed consent and assent forms prior to participating in the intervention program. Youth will complete pre and post surveys to measure program outcomes. Random assignment will be conducted for the impact and comparison groups by being placed into a pool; students will be blindly pulled to become the impact group. Groups will be stratified to ensure balance between treatment and comparison groups. Quarterly evaluation reports (QERs) and an annual evaluation report will be provided to the Action Team for review.
Capacity Builder's Inc. (CBI) Youth Builders PREIS program seeks to test a modification of the Native STAND curriculum in Northwest New Mexico with at least 834 Navajo teens and 3 cohorts. The curriculum is intended to reduce pregnancies, births, and STI's including HIV/AIDS among high-risk youth populations by implementing culturally sensitive curriculum based on Navajo positive youth development. Additional curriculum of adulthood preparation subjects will increase participant knowledge in the areas of: healthy relationships, adolescent development, communication skills, healthy life skills. Youth Builders will be delivered within the traditional school day, embedded into regularly scheduled learning time. Presented once each week for 27 weeks over a 36-week school year, Youth Builders will reach students where they are, overcoming many challenges associated with retention. The project will support a Randomized Controlled Experimental Design. CBI will create valuable resources to support Youth Builders replication nationwide, including a comprehensive Youth Builders Blueprint, describing all action steps taken to achieve goals and objectives. In addition to action steps, the Youth Builders Blueprint will include: program curriculum; curricular map; training materials; sample parent consent forms; sample referral procedures / policies; staff training schedules; sample partnership agreements; Action Team meeting minutes,QERs, and annual evaluation reports The Youth Builders Blueprint will be available in both print and online format, and will be widely disseminated throughout the CBI network of non-profit agencies, Tribes, and school districts across the United States. Conference presentation will be ongoing at state and national conferences.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kristen Rivas, MS Ed, LADC
- Phone Number: 775-690-5992
- Email: orivasconsulting@charter.net
Study Locations
-
-
New Mexico
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Farmington, New Mexico, United States, 87401
- Recruiting
- Capacity Builders Inc.
-
Contact:
- Lois Ritter
- Phone Number: 148 505-326-4245
- Email: l.ritter@capacitybuilders.info
-
Principal Investigator:
- Lois Ritter
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Between the ages of 14-18
- In grades 9-11
- Provide parental consent and participant assent to participate in the study
- Students in the first two groups will be allowed to participate in the intervention if they are enrolled in the classroom that will be receiving the intervention
- Students in the third group will be allowed to participate in the intervention only if they were part of the study's intervention group
Exclusion Criteria:
- Not have previously participated in any of the following past CBI Teen Pregnancy
Prevention programs:
- New Mexico's Department of Health - Wyman's Teen Outreach Program
- Success with Adolescent Goals, inclusive of the Above the Waist Curriculum
- Students in 12th grade
- Study participants from previous cohorts
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Impact group
The impact group will receive the interventions in the classrooms
|
Native STAND is a comprehensive sexual health curriculum for Native high school students that focuses on sexually transmitted infections, HIV/AIDS, and teen pregnancy prevention, while also covering drug and alcohol use, suicide, and dating violence.
Twenty-seven sessions support healthy decision-making through interactive discussions and activities that promote diversity, self-esteem, goals and values, team building, negotiation and refusal skills, and effective communication.
Sessions will be conducted in regular Physical Education and/or Health Education classes during classroom/school hours.
|
PLACEBO_COMPARATOR: Comparison group
Comparison group will not receive the intervention
|
General health and physical education curriculum provided by New Mexico's Public Education Department.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abstaining from sexual activity
Time Frame: pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
|
Do students assigned to the Youth Builders program have a greater chance of abstaining from sexual activity (i.e.
oral, vaginal and anal) in the last 3 months compared to students assigned to the comparison group at 12 month follow up and 18 month follow up? (No vaginal sexual intercourse, report abstinence at 12 and 18 random assignment month follow up?
|
pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
|
Abstaining from sex or practicing safe sex
Time Frame: pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
|
Do students assigned to the Youth Builders program have a greater chance of abstaining from sex or practicing safe sex (i.e. using a male or female condom, or other means of birth control if they have sex), than students assigned to the comparison group at 12 month follow up and 18 month follow up? (No sexual activity or use contraception if engage in sex at 12 and 18 month follow up)?
|
pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive impact on participants' assertive communication/negotiation skills
Time Frame: pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
|
To what degree does the Youth Builders curriculum have a positive impact on participants' assertive communication/negotiation skills?
|
pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
|
Positive impact on the peer to peer communication/discussing expectations habits of participants
Time Frame: pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
|
To what degree does the Youth Builders curriculum have a positive impact on the peer to peer communication/discussing expectations habits of participants?
|
pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
|
Positive impact on the family communication/discussing expectations habits of participants
Time Frame: pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
|
To what degree does the Youth Builders curriculum have a positive impact on the family communication/discussing expectations habits of participants?
|
pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Greater chance of not becoming (female) or getting (male) the opposite sex pregnant, than students assigned to the comparison group at 12 and 18 months after random assignment
Time Frame: pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
|
Do students assigned to the Youth Builders program have a greater chance of not becoming (female) or getting (male) the opposite sex pregnant, than students assigned to the comparison group at 12 and 18 months after random assignment?
|
pre test, post test after 27 lessons, short term follow up at 12 months, long term follow up at 18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lois Ritter, Capacity Builders Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 90AP2687-01-00
- 90AP2687-00 (OTHER_GRANT: Family and Youth Services Bureau)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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